hcv diagnostics market intelligence report 2017 · 2019. 4. 3. · find/chai diagnostics market...
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HCV Diagnostics
Market Intelligence Report 2017
First Report on Screening and Diagnosis Market Growth
FIND/CHAI Diagnostics Market Intelligence Report 2
FIND/CHAI Diagnostics Market Intelligence Report 3
Summary In order to close the diagnosis gap and reduce barriers to accessing diagnostics in low- and middle-
income countries (LMICs), the Foundation for Innovative Diagnostics (FIND) and the Clinton Health
Access Initiative (CHAI), with support from Unitaid, surveyed 29 LMICs and worked closely with 44
suppliers and in-country partners worldwide to gain market intelligence insights into the hepatitis C
virus (HCV) diagnostic landscape. Categories analyzed include program structure, trends in
procurement, testing rates, national targets, and obstacles to scale-up. A five-year forecast of the total
market need and the projected demand for HCV diagnostics was developed for the 29 LMICs
representing 80% of absolute HCV viremic burden in LMICs, plus high relative prevalence countries
with active HCV programs (see Appendix A for country list).
The total market need and demand for screening tests over the next five years is estimated to be
respectively 826 and 178 million tests, of which 75% is driven by five countries (China, Pakistan,
Egypt, Brazil and Morocco). While lab-based immunoassays (IAs) are mainly used for screening of
HCV in middle-income countries, most low-income countries surveyed are shifting towards the use of
rapid diagnostic tests (RDTs) as the main method of screening, primarily for cost and access reasons.
The market for screening tests is highly fragmented, with an average of five RDT or IA brands being
procured per country, although some of these tests, particularly RDTs, are of unknown quality. While
the average price per test stays generally under $1 in the public and private sectors, there are some
major disparities between countries and brands. These differences are heavily influenced by
purchasing volumes, competition and local importation and taxation costs.
The total market need and demand for viral load tests over the next five years for high-burden LMICs
is estimated at respectively 31 and 16 million tests, of which 79% is driven by four countries (China,
Egypt, Pakistan and India). An increasing number of LMICs are adopting policies and guidelines to
simplify their HCV diagnostic algorithms and are also exploring various service delivery models to
account for the needs of different high-risk groups. The viral load testing market is rather consolidated:
the two market leaders – Roche and Abbott – offer platforms used mainly by countries in centralized
laboratory settings. Another fast-growing manufacturer, Cepheid, provides decentralized testing with
its GeneXpert platform. The majority of countries have HCV assays from Roche and Abbott registered
and available. Most countries have already or are in progress of registering and using GeneXpert
HCV assays. The analysis has noted excess capacity on major platforms so that the integration of
testing for HCV alongside other diseases such as HIV and TB is feasible. HCV viral load testing pricing
remains high in most countries (from $15-$30 per test in the public sector to $60-$200 per test in the
private sector) and was noted by survey respondents as a significant barrier to program scale-up.
Many stakeholders have been advocating for a shift to core antigen (cAg) testing - which may enable
a one-step diagnosis more easily than nucleic acid testing (NAT) – and some global treatment
guidelines have recommended it as an option for confirmatory testing. Considering a gradual scale-
down of on-treatment monitoring tests and other factors, the total need for cAg testing over the next
five years is projected to be 285 million tests. Very few cAg assays are available commercially and
they range widely in quality. The Abbott ARCHITECT HCV cAg assay is one of the best performing
options; however, most LMICs do not have the Abbott ARCHITECT 2000 platform in place to be able
to conduct cAg testing. In the long-term, widespread adoption of cAg testing will require factors such
FIND/CHAI Diagnostics Market Intelligence Report 4
as more quality-assured supply options, competitive pricing to allow for use in screening, affordable,
point-of-care (POC) cAg platforms, and/or greater availability of Architect platforms.
Six obstacles have been identified and need to be addressed in order to increase diagnostic coverage
and help scale up HCV programs in LMICs. Firstly, despite a noticeable shift towards greater
investment in HCV, a majority of countries still have inadequate funding to meet the WHO’s 2020/2030
HCV elimination targets. Secondly, suboptimal device placement or inadequate testing capacity within
laboratory networks prevents scale-up of HCV programs. Integration of HCV/HIV/TB testing on the
existing platforms could be a solution although there are governance and systems challenges that
must be addressed. Thirdly, lack of healthcare worker engagement on HCV due to lack of knowledge
requires additional training resources, integration of HCV care into existing systems, and use of
innovative models to target high-risk patients. Fourthly, most countries lack key data on HCV patients,
impeding their ability to develop well-informed national strategies and engage with suppliers on pricing
negotiations. Fifthly, very few countries have clear diagnostic targets or scale-up plans for HCV in line
with the WHO’s 2020/2030 HCV elimination targets. Identifying and setting such targets is crucial to
advocating for HCV funding, planning for procurement, developing appropriate service delivery
models tailored to the national context and locating sources of technical support and partnership.
Finally, limited awareness of HCV in the general public is a key challenge: embarking on education
and awareness programs in-country will lower stigma about HCV, stimulate demand for services, and
increase case-finding.
FIND/CHAI Diagnostics Market Intelligence Report 5
Acronyms AASLD American Association for the Study of Liver Diseases CAGR Compounded annual growth rate
cAg Core antigen CBO Community-based organization CHAI Clinton Health Access Initiative CoNE Community Network for Empowerment (Manipur, India) DAAs Direct-acting antivirals EASL European Association for the Study of the Liver FIND Foundation for Innovative Diagnostics GX GeneXpert HCV Hepatitis C virus HIV Human immunodeficiency virus IA Immunoassay LMIC Low- and middle-income country LTFU Loss-to-follow-up
MDR-TB Multidrug-resistant tuberculosis
MSF Médecins sans Frontières
NAT Nucleic acid testing
NGO Non-governmental organization
NSP Needle/syringe programs
OST Opiate substitution therapy
PLHIV People living with HIV
PWID People who inject drugs
POC Point-of-care RDT Rapid diagnostic test SVR (SVR12) Sustained virologic response (12 or more weeks after the end of treatment) TB Tuberculosis
VL Viral load
WHO World Health Organization
FIND/CHAI Diagnostics Market Intelligence Report 6
Overview Approximately 71 million people worldwide are chronically infected with HCV, establishing it as one
of the world’s most common infectious diseases.i More than 80% of these people live in LMICs.
Over the last fifteen years, mortality has steadily increased to over 400,000 deaths annually, in stark
contrast to the declining number of deaths seen for other infectious diseases such as HIV, TB and
malaria.ii Despite its high prevalence, morbidity and mortality, only 20% of HCV-infected persons
have been diagnosed and only 7% have received treatment worldwide.iii In LMICs, rates of
diagnosis and treatment are even lower.iv
Figure 1: Cascade of care for HCV infection, by WHO region, 2015
Closing the diagnosis gap is crucial for countries to achieve the 2030 elimination targets they
committed to at the 2016 World Health Assembly. However, rates of diagnosis and the diagnostic
access barriers in LMICs have not been well-characterized to date. As a result, investment in improved
tools and commitment from suppliers to lower prices has been limited despite the release of the WHO
guidelinesv on testing, strategic diagnostic approaches, solving access barriers, and linking patients
to treatment. To address these information gaps, FIND and CHAI, with support from Unitaid, sought
to develop a first-ever HCV diagnostic market forecast for LMICs and analyze the enablers and
barriers to growth with the aim of providing adequate market transparency to stimulate investment in
HCV diagnostics at the supplier level while identifying concrete actions to improve access in local
markets. This report highlights the key findings and insights from this analysis for HCV screening, viral
load/core antigen testing, overall market growth potential, and barriers to scale.
Methodology CHAI and FIND, with the support of Unitaid, surveyed 29 countries and 44 partners/suppliers
worldwide to gain market intelligence insights into the HCV diagnostic landscape, including program
structure, trends in procurement, testing rates, national targets, and obstacles to scale-up. CHAI built
FIND/CHAI Diagnostics Market Intelligence Report 7
a five-year need and demand forecast to project the total market need for HCV diagnostics and the
actual projected demand for the highest-burden HCV countries globally. This market intelligence
assessment covers low- and middle-income countries that represent 80% of the total global HCV
burden, in addition to several other high prevalence countries that are currently contributing a
disproportionate amount of diagnostic volumes due to their ambitious public programs, even though
their relative absolute burden is small, such as Georgia. See Appendix A for list of these countries.
Figure 2: Countries selected for market assessment
The approach to data collection included:
1. Supplier surveys to determine actual diagnostics platform capacity/footprint and past and
future orders data
2. Market intelligence survey shared with 44 partners to better understand country programs,
procurement, funding, algorithms, and future scale-up plans
3. Partner interviews, surveys, and data requests in key geographies
4. An in-depth desk review of all published data and policy documents to assess available
information on country-level HCV programs
5. Extensive assessments of the HCV program in 5 countries, including stakeholder interviews
The 5-year HCV need forecast leveraged Polaris Observatory country data on existing/new HCV
infections and patients diagnosed/treated to calculate the total number of patients requiring diagnosis
each year to meet the WHO targets of 30% diagnosed by 2020 and 90% diagnosed by 2030. The
number of screening and viral load tests was calculated factoring in chronicity rates, prevalence,
testing algorithm, and false negative rates.
The 5-year demand forecast was defined as the number of tests likely to be consumed by the market
and represents assumptions and expectations in light of currently available information. This forecast
is based on a number ofs factors relating to a country’s capacity to scale up HCV testing, and it thus
involves uncertainty. The innovative demand forecasting approach is based on a number of analogue
FIND/CHAI Diagnostics Market Intelligence Report 8
countries which were identified to represent a range of scale-up scenarios. Forecasts were then
developed using available data for the analogue countries. The remaining countries were mapped to
analogue scale-up scenarios according to a scoring index that included factors such as prevalence,
guidelines/strategic plans, level of government commitment to HCV, level of HCV financing and
general health funding, existing lab capacity, price of diagnostics, and planned procurements. Table
1 gives details of these scoring index factors.
Table 1: Index factors for country mapping
Policy Funding and procurement Program capacity
Index factors Max score
Index factors Max score
Index factors Max score
Viremic prevalence 8 Financing availability
18 Level of lab capacity 6
Strength of advocacy 4 HCV funding 16 HIV VL program maturity 2
DAAs in guidelines 4 Diagnostics procurement levels
8 HCV diagnostics cost 4
DAAs in use 8
GeneXpert approval 2
National Strategic Plan 4
Active screening 8
Demand generation 8
Subtotal 44 Subtotal 42 Subtotal 14
TOTAL INDEX FACTORS MAX = 100
Growth rates for analogue countries in each category were then applied to the remaining countries to
deduce global estimates. Furthermore, forecasts were developed for the highest-burden countries
individually when data was available in order to increase projection accuracy. Table 2 provides details
of 10 analogue countries that were selected due to the availability of enough data for more robust
predictions and the countries that were mapped to the analogue countries.
Table 2: Country mapping to analogue countries under different scenarios
Scenario 1 Scenario 2 Scenario 3 Scenario 4 Scenario 5
Country description
Limited access to funding or political will to scale program
Initial public program progress, but limited in scale
Significant scale-up to date, but not yet on elimination track
Upper middle income countries who may be constrained by drug pricing
Countries on elimination track
Index score range
5 – 25 26 – 39 40 – 55 56 – 75 76 - 100
Analogue countries
Ethiopia Myanmar Punjab (India) Brazil Georgia
Cameroon Colombia China Thailand Mongolia
Other countries
Philippines Nigeria Pakistan Russia Egypt
Syria Indonesia India Romania Ghana Algeria Uzbekistan Mexico Cambodia South Africa Turkey Argentina
Malaysia Morocco
Kazakhstan
FIND/CHAI Diagnostics Market Intelligence Report 9
Screening
Screening forecast
The total market need for screening tests over the next five years for high-burden LMICs is estimated
to be 826 million tests. The total projected demand for screening tests over the next five years for
LMICs is 178 million tests, which accounts for a number of factors relating to a country’s capacity to
scale up HCV testing. Three quarters (75%) of screening test demand was driven by five countries
(China, Pakistan, Egypt, Brazil, Morocco). It is important to note that the total market need for
screening tests trends downward as it approaches 2020 and countries get closer to meeting the WHO
target of 30% diagnosed, hence a negative total compounded annual growth rate (CAGR) of -4.6%
over the five years. The market need returns to a positive trajectory when the WHO diagnosis target
changes to 90% in 2020. The forecasted demand projection for screening tests, however, increases
at a CAGR of 7.2% over the five years, highlighting that countries are increasing screening activities
for HCV but not at the pace required to meet the WHO target for diagnosis. The gap between need
and demand is influenced by low rates of active screening, and the difference between theoretical and
actual tests needed to find the target number of patients. However, the need forecast does not take
into account whether countries are screening for high-risk populations, so countries doing prioritized
screening may reach WHO targets with far fewer screening tests than estimated here.
Figure 3: Estimated Annual Need to Meet WHO’s 2030 Elimination Targets vs. Annual Demand for Screening Tests 2017-
2021
Screening policy
Most surveyed countries have guidelines which recommend RDTs as an acceptable method of
screening for HCV in addition to lab-based IAs. Historically, IAs have been more commonly used in
most countries where HCV programs are limited to large tertiary care facilities with hepatology
services. However, a shift to primarily using RDTs is being seen in many low-income countries as they
expand their programs geographically while contending with less developed laboratory infrastructure.
Several CHAI hepatitis program countries have recently started or completed RDT validations for this
reason, and noted using RDTs for cost and access reasons.
210
187
161
103
166
22 28 36 4151
-
50
100
150
200
250
2017 2018 2019 2020 2021
Mill
ion
s o
f Sc
ree
nin
g Te
sts
Need Demand
FIND/CHAI Diagnostics Market Intelligence Report 10
This trend of screening with RDTs is expected to accelerate as countries look to expand screening.
With the challenges of underdeveloped laboratory networks, low levels of infrastructure, high
transportation costs, unequal access to laboratory facilities, and a dearth of skilled laboratory
technicians, countries are gravitating towards the ease of using RDTs to avoid long turnaround times
and patient loss-to-follow-up (LTFU). RDTs will prove to be
particularly useful as countries actively begin screening
patients for HCV infection, focusing on high-risk populations
that may be hard to reach (e.g., PWID). In middle-income
countries, IA platforms are still being used extensively due to
their relatively stronger existing laboratory capacity,
infrastructure, health workforce, and transportation networks.
To achieve diagnosis targets, programs will need to find
patients who are asymptomatic, requiring active screening
strategies such as provider-initiated screening, risk-based
screening, index tracing, and systematic screening of high-risk
groups, and general population campaigns. However, the
number of high-burden countries that are actively screening
patients or targeting high-risk populations for prioritized
screening remains low. In most countries, the patients being
diagnosed with HCV are presenting to clinics with acute
symptoms or advanced illness. Only 10 out of 29 analyzed countries (35%) had active screening
programs in place, and all were middle- or lower-middle income countries.
However, countries are moving towards active screening, as evidenced in changes to recent
guidelines which list key populations for screening. Of CHAI hepatitis program countries, 100% of the
countries list PLHIV and PWID as populations prioritized for screening. Of profiled countries, 60%
prioritized prisoners and hemodialysis patients and 40% focused on pregnant women, children born
to HCV-infected mothers, people with a history of blood transfusions, and/or people with tattoos or
surgical procedures conducted in places with weak infection control procedures under priority
population for HCV screening. Only 20% of surveyed countries included healthcare workers and
female sex workers as key populations prioritized for HCV screening.
Procurement
Few countries surveyed provided detailed screening test procurement or consumption data and very
few provided a breakdown between the use of laboratory-based IAs versus RDTs. In many of the
countries surveyed, screening test procurement is a hospital-level responsibility and
procurement/consumption data is not reported to national hepatitis programs. Where data was
available, volumes were inconsistent from year-to-year in most countries, concordant with a passive
approach to case finding. Furthermore, few national programs have provided direction or guidance on
product selection, which may hinder procurement of high-quality, cost-efficient screening tests. As a
result, screening test procurement is highly fragmented (a significant number of countries have more
than five RDTs registered) and test performance is highly variable. Nine LMICs were analyzed in a
previous internal study by CHAI and were found to be using 46 different RDTs for HCV screening
collectively. A subset of these tests and the number of countries using each test is shown below.
The Rwanda Biomedical
Center pursued active
screening through campaigns
targeting risk groups. In 2016,
RBC screened 65% of its HIV
population in care over 6
months, identifying more than
4% of its ART cohort as
antibody-positive. In 2017,
follow-up campaigns were
conducted in prisons, targeting
people over age 40, which are
two other risk groups.ix
FIND/CHAI Diagnostics Market Intelligence Report 11
Figure 4: Number of surveyed countries procuring RDT/IA Brands
Forecasting procurement of screening tests was also difficult as many countries have not set HCV
screening targets, even though they may have treatment targets. Absence of historical antibody
positivity rates captured by data systems made it difficult to forecast the number of screening tests
needed to hit treatment targets.
Payment and pricing
Pricing for screening tests is generally low but can vary significantly country-by-country depending on
the test brand. The price paid to distributors by public or private purchasers is generally quite low,
although it is heavily influenced by purchasing volumes, competition and local importation and taxation
costs. Where patients pay for testing, the price fluctuates depending on whether the patient goes to a
public or private clinic for treatment, cold chain storage needs, sample type, and sample
transportation. There is currently only one oral-fluid test that is commercially available in the surveyed
countries (OraQuick/OraSure), which is priced much higher than blood-based RDTs. FIND has
purchased RDTs for $1 for many of its country programs. The graph below highlights the range of
prices to the patient for RDTs.
A) FDA approved B) WHO PQ C) CE Mark
FIND/CHAI Diagnostics Market Intelligence Report 12
Figure 5: Number of surveyed countries in various RDT price per test ranges
Demand for screening tests is heavily influenced by whether the patient must pay out-of-pocket. Few
countries offer systematic free testing for their populations in the public sector. Among CHAI hepatitis
program countries, only one country offers free screening to public sector patients and only in some
regions while two countries offer free screening only for patients covered under national health
insurance. A third country offers free testing to high-risk populations (PLHIV, PWID, prisoners,
pregnant women) only through certain demonstration pilots, not nationally. In some countries,
screening is covered under insurance programs, but limited to patients who are either admitted to the
hospital or who exhibit symptomatic disease. Where countries have begun to provide testing free-of-
charge, this is often still limited to a small number of hospitals or entry points within hospitals.
Partner involvement
NGOs and CBOs are catalyzing countries to conduct wider
screening and actively seek out HCV-infected patients. NGOs
have a significant role to play in galvanizing and re-allocating
funding for HCV efforts, tracking screening volumes and
yields, corralling stakeholders for HCV efforts, and advocating
to the government for crucial policy and strategy changes in
HCV diagnosis and treatment. Organizations that were found
to be actively supporting screening across a number of
countries include Médecins du Monde, that screening injecting
drug users in Côte d’Ivoire, Georgia, Kenya and Vietnam;
MSF, that is running demonstration projects in Cambodia,
India, Mozambique and Myanmar, and Coalition Plus, that
supports a diverse group of CBOs in Colombia, India,
Indonesia, and Morocco.
22
5
1 1
0
5
10
15
20
25
$0 - $1 $2 - $5 $5 - $15 >$20
Nu
mb
er
of
cou
ntr
ies
Price per RDT test**Pricing is ex-works
The Community Network for
Empowerment (CoNE) in India
collaborated with the
government and pharma
companies to screen over 1,000
high risk individuals at 13 sites,
supported by road shows to
generate disease awareness.
They found 494 antibody-
positive patients who were
subsequently linked to
confirmatory diagnosis and
treatment.
FIND/CHAI Diagnostics Market Intelligence Report 13
Viral load
Viral load forecast
The total need for viral load tests over the next five years for high-burden LMICs is estimated at 31
million tests. Need was calculated in a similar manner for screening tests, using the 2020 and 2030
WHO targets for diagnosing HCV patients. The total projected demand for viral load tests over the
next five years for LMICs is 16 million tests, which factors in planned procurement data, historical
demand, funding, country targets, and a number of other aspects relating to a country’s capacity to
scale up HCV testing. Of the projected demand for viral load tests, 79% was driven by four countries
(China, Egypt, Pakistan, India), with Egypt driving the most significant portion of total demand (36%).
Like the need forecast for screening tests, the need forecast for viral load tests shares a similar
downward trajectory (CAGR of -11.4%) as countries approach the 30% diagnosis target in 2020 and
moves upward as the targets change to 90% for diagnosis in 2030. The viral load need forecast’s
CAGR decreases at a greater pace than that for screening tests as it accounts for countries reducing
the number of viral load tests in their algorithm down to 2 tests by 2021. The viral load demand
forecast grows at a CAGR of 5.1% over the next five years, demonstrating a steady increase as
countries set their sights on diagnosing more patients.
Figure 6: Annual need for WHO’s 2030 elimination targets vs. annual demand for confirmation and monitoring tests 2017-
2021
8.9
7.9
5.6
3.6
4.9
2.9 3.1 3.3 3.5 3.7
-
1
2
3
4
5
6
7
8
9
10
2017 2018 2019 2020 2021
Mill
ion
s o
f D
iagn
ost
ic T
est
s
Need Demand
FIND/CHAI Diagnostics Market Intelligence Report 14
Viral load policy
An increasing number of countries, specifically low- and lower-middle
income countries, are adopting policies and guidelines to simplify their
HCV diagnostic algorithms. This includes decreasing the total number
of viral load tests to diagnose and monitor patients (down to 2 in total),
as well as shifting away from requiring genotyping prior to HCV
treatment initiation. These trends can be a catalyst for program scale-
up and rapid growth, and reflect the increasing availability of direct-
acting antivirals that are effective across all genotypes.
NAT platforms
Only a few companies worldwide market HCV nucleic acid testing, of
which Roche and Abbott are the two main suppliers of viral load tests
for HCV in both low- and middle-income countries. Roche is the market
leader in sales, followed by Abbott, although Cepheid is gaining market share since the launch of its
HCV cartridge for GeneXpert in 2015. Roche and Abbott platforms tend to be found in laboratories in
the private sector and in tertiary or district hospital-level laboratories in the public sector, where they
have often been placed for use by HIV programs. Cepheid platforms tend to be more decentralized
and have been placed by TB programs historically to screen PLHIV for TB and those suspected to
have MDR-TB. Most countries surveyed noted available capacity on HIV and TB testing platforms,
which could also accommodate HCV testing on existing devices. However, the challenges on how to
make this integration possible and acceptable across programs, given the situation around
governance, funding, and oversight still remains to be addressed in most countries.
Total viral load testing capacity on major platforms in 25 out of 29 LMICs included in the forecast is
estimated to be over 17 million tests per year. The highest projected annual need for HCV testing is
8.9 million viral load tests (2017) and the highest projected demand is 3.7 million viral load tests (2021),
indicating there likely is excess capacity available on existing platforms to accommodate HCV testing.
An internal analysis by CHAI of 2017 Cepheid TB sales data indicates that 83 out of 120 countries
(69%) are using less than 25% of their GeneXpert installed base capacity. Additionally, Cepheid’s
2017 TB sales data indicate that 111 out of 120 countries (92%) are using less than 50% of their
installed base capacity. This analysis further indicates there is ample available capacity to integrate
HCV testing on existing GeneXpert platforms in LMICs.
Countries expanding their HCV programs have made different decisions about which platforms to use
according to their context. Sites with lower expected testing volumes or where there is a mismatch
between the location of a centralized platform and the HCV disease burden have opted to use Cepheid
GeneXpert devices. Where integration of testing on existing platforms has proven politically
challenging, countries have found purchasing new GeneXpert devices to be the most financially
feasible option for expansion of diagnosis. Other countries have found it most feasible to integrate
HCV testing into their existing sample transport networks for testing at centralized laboratories on
Abbott or Roche platforms. All of the 29 countries surveyed had in-country registration of HCV assays
from Roche or Abbott and 21 countries had already registered or were in the process of registering
GeneXpert’s HCV assay.
Until 2017, Nasarawa State in Nigeria had no access to nucleic acid testing for any
disease. In partnership with HealthLine and
Cepheid, Nigeria is piloting an HCV/TB
integration strategy on Cepheid’s GeneXpert
platform.
FIND/CHAI Diagnostics Market Intelligence Report 15
Figure 7: Status of registration of GeneXpert use for HCV Viral load testing in high burden countries
Some middle- or lower-middle income countries such as China, Georgia, and India are also using
open source viral load testing platforms, which be lower priced and can potentially use reagents from
multiple suppliers. However, use of open source VL testing platforms often requires increased training
and rigorous quality assurance to ensure consistent provision of accurate test results. Open source
platforms also create more complexity in a country’s supply chain due to the need to procure various
commodities from multiple suppliers.
Service delivery models
A number of service delivery models are in place for HCV viral load testing. As countries continue to
explore integration of HCV testing into their existing systems and deal with changing disease
demographics, these service delivery models may shift or merge in the future. It is noteworthy that
WHO and other partners strongly advocate for differentiation of
service delivery models as the needs of the general population
can differ from high-risk groups, and even within diverse high-
risk groups there are significant differences. Countries are
testing different models, depending on their device throughput
and current diagnostic systems structure.
The Mukht Mantri Hepatitis C Relief Fund in Punjab State,
India, covers the cost of treatment for all citizens of the state. The government has negotiated a deal with
private sector laboratories to charge patients $30 for their two viral load tests (prior to
and upon completion of treatment).
Table 3: Details of different service delivery models for HCV VL testing
Service delivery model
Country example
Description Advantages Disadvantages
Testing at centralized laboratories
Nigeria, Vietnam
Patients are screened at lower-level health facilities and then are referred to the laboratory at the central hospital for testing
Consolidation of testing; ability to use higher throughput machines
High travel time and expense for patients; limited access to testing for many patients
Decentralized sample collection
India, Pakistan
Patients drop off samples at collection points near their homes; samples are then transported to a centralized facility for processing
Leverages existing sample transport networks
Long turnaround times for results delivery can be an issue
Centralized GeneXpert (GX) testing
Myanmar Patient samples are sent to central laboratories for testing on dedicated GX platforms
Potential to scale HCV testing quickly; no integration challenges
Volumes limited by small number of devices, potential overcapacity in the lab system, long turnaround time
Decentralized and integrated GX testing
Indonesia, Nigeria pilots
Patients are tested on GX platforms at lower-level health facilities shared with HIV and TB programs
Leverages already-deployed GXs; higher utilization of machines
If platforms and HR are already near capacity, ability to leverage existing systems may be limited
Payment and pricing
HCV viral load testing pricing remains high in most countries and was noted by survey respondents
as a significant barrier to program scale-up. Despite the small selection of platforms, reagent pricing
was found to be highly variable, differing not only greatly across geographies but also within countries
according to where services are being offered (NGOs, public, or private sector) and who is paying for
the tests. Where free testing is available in the public sector or testing is offered through donor or
NGO-funded programs, funders were paying between $15 and $30 per test, although middle-income
countries faced higher pricing. Variation is both due to in-country customs, taxes, and distribution
costs, as well as low and uncertain purchase volumes which impede negotiations for price reductions.
Where payment in the public sector was out-of-pocket for patients, countries reported testing costs in
the $40-$100 range. The higher price largely seems to be explained by hospital margins and the need
to incorporate small batch sizes and uncertain demand into final prices. Private sector pricing was
more variable, with pricing as high as $200 for one viral load test. These prices often exceed the
disposable income available to patients, preventing patients from accessing confirmatory diagnosis
and initiating treatment.
Figure 8: Reported pricing structure by industry segment for HCV Viral load testing in high burden countries
A number of countries surveyed have started publicly-funded HCV treatment programs, but still require
patients to pay for their viral load tests. Additionally, some health insurance programs limit
reimbursement of viral load testing to those who are admitted for inpatient care. These restrictions will
continue to hamper demand for diagnosis services and impede countries from reaching their treatment
targets.
The cost of HCV diagnostics and treatment is a significant factor in whether patients present for
confirmatory testing, start treatment, complete treatment, and return for the final SVR test. In particular,
several countries, including Egypt, Georgia and the state of Punjab in India have reported challenges
in having patients return for their SVR12 test. Striving for the provision of free HCV diagnostics in the
public sector will be a key to reducing patient LTFU.
Core antigen
Need forecast
Many stakeholders have been advocating for a shift to core antigen (cAg) testing, which may enable
a one-step diagnosis more easily than nucleic acid testing. This strategy could be of particular value
for centralized testing settings or in countries focused on elimination and implementing of a test-and-
treat strategy for HCV. Clinical data on the feasibility, accuracy and cost of cAg needed to justify a
one-step testing strategy is still needed. Given the uncertainty on whether normative guidance (EASL,
AASLD or WHO) would recommend this testing approach, a five-year need forecast was modeled for
cAg testing based on WHO targets, including a gradual scale-down of on-treatment monitoring tests,
and based on the assumption that the algorithm evolves as outlined in Table 4.
To implement this algorithm, the total need for cAg tests over the next five years is projected to be 285
million tests. The need increases significantly in 2020 once the algorithm incorporates core antigen
for one-step diagnosis and also factors in the further increase in WHO diagnosis targets.
$0
$50
$100
$150
$200
$250
Public Sector/NGO -Free
Public Sector - PatientsPay
Private Sector
Pri
ce p
er T
est
High End Low End
$15-$30
$30 - $100
$60-$200
FIND/CHAI Diagnostics Market Intelligence Report 18
Table 4: Assumed algorithm to model need forecast for core antigen testing and total cAg tests needed
2017
2018
2019
2020
2021
Assumed cAg algorithm
RDT/IA screening;
cAg diagnosis;
NAT SVR12
RDT/IA screening;
cAg diagnosis;
cAg SVR12
RDT/IA screening;
cAg diagnosis;
cAg SVR12
cAg diagnosis;
cAg SVR12
cAg diagnosis;
cAg SVR12
Total of cAg tests needed
3,247,156 2,905,211 5,269,993 104,225,897 169,077,660
Figure 9: Annual HCV diagnostic needs 2017-2021, with adoption of cAg testing
Uptake
Core antigen testing has been recommended in some global treatment guidelines as an option for
confirmatory diagnosis only, as evidence is still emerging on its accuracy to confirm cure post-
treatment. However, its use is not yet widespread. Very few cAg assays are available commercially
and they vary in quality. The Abbott ARCHITECT HCV cAg assay is one of the best options, but is
run on a high-throughput ARCHITECT 2000 platform, which is not widely available in LMICs. A few
countries noted only 1-2 platforms available nationally. Although experts predict that core antigen
pricing could be lower than viral load pricing in the future, more favorable pricing has yet to be seen,
making this a key barrier to cAg uptake. Several countries, such as Cameroon and Georgia, are
piloting cAg testing to streamline the HCV diagnostic algorithm to one-step diagnosis. In the short-
term, countries with existing ARCHITECT platforms and who are using IA-based screening are likely
to be the first to use cAg testing. Longer term, widespread adoption of core antigen testing would
require competitive cAg pricing for general screening, the development of less expensive and more
210
187
161
- -6 3 - - -3 3 5
104
169
-
50
100
150
200
250
2017 2018 2019 2020 2021
Mill
ion
s o
f T
est
s
Screening Tests VL Tests cAg Tests
FIND/CHAI Diagnostics Market Intelligence Report 19
point-of-care platformsvi. Besides, the availability of new pan-genotypic, highly-effective DAAs could
allow countries to further simplify their testing algorithms if they have not already (e.g. elimination of
genotyping, or even SVR12). Adoption of HCV cAg as single step diagnosis might be the next frontier
of diagnostic simplification.
Market growth potential
Increasing demand and coverage
A large portion of the HCV-infected population lives in a small
number of high prevalence lower-middle income countries, which
have high potential to fund increased diagnostic coverage for HCV
patients. As China, Pakistan, India, Egypt, Nigeria, Russia, Brazil,
Indonesia, and Uzbekistan are estimated to have the highest
numbers of viraemic HCV infections,vii there is significant potential
for these countries to leverage their existing healthcare
infrastructure and financing to grow HCV diagnosis and treatment.
Countries in Eastern Europe (Russia,
Romania, Turkey), South America
(Brazil, Mexico, Argentina), and Asia
(Thailand and Malaysia) are also well
positioned to make HCV diagnosis
and treatment more accessible to
their citizens. Although their absolute
demand may be lower than higher
burden countries, they have strong
health systems, networks of hospitals
and laboratories, and a relatively high
level of health financing. Increasing
demand for HCV care and treatment
will be most challenging in low-income countries with low to moderate rates of prevalence, where
garnering the political will, public commitment, and financing to scale up their programs will be difficult
without donor support. However, these countries will benefit from economies of scale in diagnostic
pricing achieved by larger markets, which will continue to make diagnosis and treatment more
affordable.
Obstacles to growth Despite the growth potential of the diagnostics market for HCV, the analysis identified six key
obstacles to growth that will limit scale-up of HCV programs and the coverage of diagnostics in LMICs
if left unaddressed. Additionally, potential interventions to address each obstacle have been
recognized.
The country of Georgia has developed a public-
private partnership where Gilead contributes DAAs
and the government covers the cost of
screening, diagnosis and SVR12 for patients, with technical assistance from
the CDC.
FIND/CHAI Diagnostics Market Intelligence Report 20
Funding
Only five out of 29 countries had high levels of funding for HCV, characterized by the presence of a
dedicated national HCV budget which was estimated to be sufficient to meet or exceed the WHO 2020
targets. Almost 60% of countries were assessed as having low levels of funding for HCV. Almost all
funding was domestic, although some countries are currently benefitting or plan to benefit from
Unitaid-funded projects with MSF and FIND, and a few countries have small amounts of funding for
HIV/HCV co-infected patients through the Global Fund. Several countries also benefit from DAA
donations from originator companies. With domestic funding, treatment has often been prioritized over
diagnostics. Pricing for HCV drugs in countries without access to generics remains high, serving to
curtail interest from governments in providing widespread free diagnostic services for an illness if they
can only afford to treat a few patients. Treatment pricing in generic-accessible countries is coming
down rapidly, stimulating the launch of new programs, although the financial ability to scale up is still
in question. Some low-income countries are constrained by small health budgets and lack of national
health insurance systems, but many lower-middle income countries may have adequate fiscal space
to allocate increased funding to diagnostics and treatment for HCV, especially in light of possible cost
savings.
There has been a shift towards greater investment in HCV by a number of partners and governments,
with a number of countries promising separate budget allocations for HCV funding in the near future.
Of CHAI hepatitis program countries, one country has committed over $7 million for treating and
diagnosing HCV patients in 2018. Another country expressed a desire to expand their HCV program
and bring more public funding to the table and benefits from a robust partner/NGO network that has
helped galvanize funding for HCV. A third country is looking to expand national health insurance
benefits to include HCV testing and treatment. A fourth country covers testing for free but only for
patients exhibiting symptoms, so many NGOs and partners in-country have committed to developing
business cases to show the benefits of expanding HCV services and including HCV commodities in
the national insurance program. A fifth country has a large number of partners and the government
has committed to including HCV as a separate budget item in 2018. While these commitments and
plans have not yet translated into measurable funding, they speak to the increasing interest of donors,
implementing partners, and governments in investing more in covering HCV services for citizens.
Given the high annual morbidity and mortality from cirrhosis or liver cancer in high-prevalence
countries, cost-benefit analyses have been useful in persuading country leadership, such as in Egypt
and Pakistan, to dedicate funding for HCV. Building advocacy coalitions between NGOs, civil society
organizations, and other stakeholders will be paramount to achieving inclusion of HCV drugs and
diagnostics into health insurance systems and essential commodities lists and will also help to
destigmatize the population affected by HCV.
Potential interventions
1 Ensure government HCV budgets and health insurance packages include the costs of screening and diagnosis; ensure screening is widely covered for citizens
2 Seek novel and feasible mechanisms for integrating HCV screening into existing activities to reduce costs and develop public-private partnerships for expanding screening
3 When possible, leverage HIV or TB budgets to strengthen cross-cutting systems that would benefit HCV programs
4 Support investment case processes in countries
5 Consolidate negotiations on a national or regional level to increase purchasing power for HCV diagnostics and to advocate for lower DAA pricing
FIND/CHAI Diagnostics Market Intelligence Report 21
Platform availability and capacity
Limited laboratory networks are a barrier to scaling up HCV
diagnostics and treatment in many high-burden countries. Actual
testing capacity on machines is less of a limiting factor; most
constraints result from suboptimal device distribution and
insufficient numbers of health workers and lab technicians to
perform tests. Low levels of human resource capacity in 31% of
surveyed countries and moderate capacity in 48% of countries
reduce the potential for rapid scale-up of HCV programs in high-
burden countries. Integration of HCV testing with HIV/TB on the
same NAT platforms can be a solution, although systems
challenges must be addressed. Political sensitivities often exist
around testing integration and local governments may have
concerns about meeting HIV or TB testing demand if existing
platforms share testing capacity for HCV patients. Vertical donor
funding or in-country program organization often exacerbate disparate disease testing and present
hurdles that need to be addressed to incorporate HCV testing into current diagnostic systems and
platforms. Strong advocacy about operational benefits of integration and collaboration across national
HIV, TB and hepatitis programs is imperative to overcome this barrier. Current pricing structures for
diagnostics also favor separate devices for individual diseases. A shift towards a more harmonized
procurement and transparent pricing across disease programs would help overcome these barriers.
The lack of sample transportation between HCV screening and referral sites is also a factor that limits
the demand of HCV testing. More integrated referral networks could help address this problem, but
will require greater coordination between programs.
Potential interventions
1 Map currently available platforms and projected capacity to identify excess/available capacity for HCV testing use
2 Conduct integration pilots to demonstrate feasibility of integration in both centralized and decentralized networks
3 Map sample transport networks to determine how HCV testing can fit into existing systems
4 Negotiate platform rental, maintenance and pricing agreements to favor platform integration
5 Identify opportunities to leverage HIV, TB or other cross-cutting programs to expand services
Health care worker capacity
Another critical capacity constraint is the limited number of healthcare professionals in LMICs who are
knowledgeable on HCV and trained to screen and diagnose the disease. In many countries, screening
for HCV has largely been limited to internal medicine or hepatology departments or through donor-
funded screening in high-risk groups. HCV is often not included in pre-service training programs for
clinicians. As a result, few frontline health care workers are assessing patients for risk of HCV and
referring for appropriate diagnosis. Training more healthcare professionals, particularly on screening
and diagnosing HCV, and using innovative models, such as Project ECHOviii, can help build the
technical capacity and comfort of health workers to care for HCV patients. Decentralizing HCV testing
and treatment to primary care settings can also reduce stigma, enhance active case-finding, and
Punjab State, India, overcame limited public
sector diagnostic capacity by outsourcing viral load
testing to the private sector. Patients drop off samples at one of the
many sample collection sites throughout the state and receive notification to return to their doctor for
results.
FIND/CHAI Diagnostics Market Intelligence Report 22
increase access to services. Integrating HCV care into existing programs targeting populations at high
risk of HCV, such as harm reduction services (OST and NSP), can also reach those who are at risk
but who may not have access to health care through other channels, at a low additional investment.
Many countries also reported chronic shortages of laboratory staff, which impedes their ability to
conduct HCV testing even when significant additional testing capacity is theoretically available on
existing platforms. Continued efforts to expand the workforce and improve laboratory work flow will be
critical to galvanize uptake of diagnostic testing without long backlogs and subsequent patient LTFU.
Potential interventions
1 Develop training packages on viral hepatitis aimed at health care workers at lower tier facilities, targeting risk factors, signs and symptoms of HCV, and referral for viral load testing
2 Train additional laboratory staff on laboratory testing for HCV
3 Train staff at central lab with high-throughput NAT platforms on patients workflow, optimization of lab resources and laboratory management
4 Evaluate current laboratory workflow practices and identify modifications for more samples to be processed weekly
5 Extend HCV screening, diagnosis and treatment to harm-reduction centers and primary care facilities with trained health care workers
6 Leverage existing patient reminder and tracking systems for HCV to reduce LTFU and ensure linkage to treatment
Inadequate data
Most countries are not tracking the volume or yields of screening or viral load tests at a national level,
impeding the development of well-informed country strategies, the proper use of diagnostic
commodities, and effective price negotiations with suppliers. Where testing is documented, test
volumes are rarely differentiated between RDTs or IAs, and not necessarily delineated between tests
done in the public sector, the private sector, or by NGOs/partner organizations. Full screening data is
rarely recorded. Without this information, it is harder for countries to plan procurement, identify national
targets, and decide where to screen. Furthermore, accurate screening data demonstrating the burden
of disease would be useful to advocate for expanding programs and increasing funding. With
fragmented procurement and weak data, governments cannot monitor or assess the effectiveness of
current screening strategies or resource allocation. Whilst viral load test volume data is more
frequently available than screening, few programs are delineating between confirmatory, monitoring,
and SVR tests. This makes it difficult for countries to measure program performance along the
cascade of care and diagnose challenges around lab turnaround time and patient retention.
Potential interventions
1 Provide screening registers at all key entry points in health facilities and collect and analyze the data regularly through national M&E systems
2 Adapt existing reporting systems to include HCV, with data reported at all critical steps of the care continuum
3 Synchronize screening and VL databases to report cascade of care numbers on national dashboards
4 Adapt laboratory information management systems to include HCV and provide information on the number of confirmatory, monitoring and SVR12 tests, as well as turnaround time data
5 Integrate HCV into national surveillance systems to monitor the epidemic and adapt programs
FIND/CHAI Diagnostics Market Intelligence Report 23
Diagnostic strategy
Few countries have concrete diagnostic targets or scale-up plans for HCV that operationalize the
WHO targets of diagnosing 30% of HCV-infected patients by 2020 and 90% by 2030. While almost
60% of analyzed high-burden or high-prevalence countries had national strategic plans for viral
hepatitis, almost none had defined diagnostic goals for the near future. Identifying and setting national
targets is crucial to fueling the process for advocating for HCV funding, planning for procurement,
developing appropriate service delivery models tailored to the national context, and locating sources
of technical support and partnership.
Potential interventions
1 Ensure strategic and operational plans and budgets include targets for screening and diagnosis, including retention rates throughout the cascade
2 Develop specific operational plans that map how HCV fits into the overall country’s laboratory strategic goals
3 Provide decision support models to countries that evaluate the optimal mix of diagnosis and treatment commodities to procure
4 Evaluate different diagnostic service delivery models for different target populations
5 Develop and implement active screening strategies
Patient awareness
Limited awareness of HCV was noted as a key challenge by countries included in the analysis.
Embarking on education and awareness programs in-country will improve the general public’s
knowledge and reduce stigma associated with HCV, leading to increased demand for testing and
improved case-finding.
Potential interventions
1 Train local NGOs to provide disease awareness education to local communities and high-risk groups
2 Support targeted information, education, and communication efforts to expand population knowledge about HCV
3 Implement advocacy and campaigning efforts to reduce stigma about HCV
Conclusion While these obstacles do represent barriers to growth for nascent HCV programs, countries, partners,
and suppliers can work together to increase investment in HCV diagnosis and treatment and
implement these programmatic recommendations to improve the diagnostic system in LMICs.
Collaboration, committed financing, and increased support at the country level will significantly
advance the global fight against HCV and reduce unnecessary morbidity and mortality for patients all
over the world.
FIND/CHAI Diagnostics Market Intelligence Report 24
Appendices
Appendix A: List of countries in scope for need and demand forecast
1. Algeria*
2. Argentina
3. Brazil
4. Cambodia*
5. Cameroon*
6. China
7. Colombia
8. Egypt*
9. Ethiopia*¤
10. Georgia*
11. Ghana*
12. India*¤
13. Indonesia*¤
14. Kazakhstan
15. Malaysia
16. Mexico
17. Mongolia*
18. Morocco*
19. Myanmar*¤
20. Nigeria*¤
21. Pakistan*
22. Philippines*
23. Romania
24. Russia
25. South Africa*
26. Syria*
27. Thailand
28. Turkey
29. Uzbekistan*
* Country that can access generic pricing for HCV treatment ¤ CHAI hepatitis program country
FIND/CHAI Diagnostics Market Intelligence Report 25
Endnotes
i Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus
infection in 2015: a modelling study. Lancet Gastroenterol Hepatol 2017; 2: 161–76. ii Global Health Estimates 2015: Deaths by Cause, Age, Sex, by Country and by Region, 2000-2015. Geneva,
World Health Organization; 2016 iii Global Hepatitis Report 2017: Geneva, World Health Organization; 2017 iv Cascade of care for HCV infection, WHO on basis of Center for disease analysis/Polaris., 2015 v WHO guidelines on hepatitis B and C testing: Geneva, World Health Organization; 2017 vi High-priority target product profile for hepatitis C diagnosis in decentralized settings: Report of a consensus meeting, FIND; 2016 vii Polaris Observatory Data viii Struminger et al. Building virtual communities of practice for health, Project ECHO (Extension for Community Healthcare Outcomes). Lancet 2017 ix Umutesi et al. Prevalence of hepatitis B and C infection in persons living with HIV enrolled in care in Rwanda BMC Infectious Diseases 2017